[Asia Economy Reporter Hyungsoo Park] GemVax announced on the 14th that it has completed Phase 3 clinical trials for its new drug candidate ‘GV1001®’ for the treatment of benign prostatic hyperplasia (BPH) and will strive to obtain new drug approval.
GemVax completed the domestic Phase 3 clinical trial of GV1001® for BPH treatment on the 18th of last month. Since 2019, clinical trials have been conducted on approximately 420 patients with benign prostatic hyperplasia at 23 hospitals nationwide.
Currently, post-clinical trial tasks including statistical data processing are underway to prepare the Clinical Study Report (CSR). The CSR is expected to be completed by the end of this year. However, considering the large scale of the clinical trial, there is a possibility that it may be delayed beyond expectations.
In 2017, GemVax confirmed improvements in the International Prostate Symptom Score (IPSS) and reductions in prostate volume through a domestic Phase 2 clinical trial involving 161 patients. The related paper received the Best Paper Award from the Korean Society of Prostate in 2018. The same year, it was also featured in the prestigious journal Nature Reviews Urology.
It was evaluated as presenting potential as a next-generation treatment for BPH, particularly because it does not cause sexual dysfunction, which is one of the side effects of some BPH treatments.
Benign prostatic hyperplasia is one of the representative male geriatric diseases that lowers the quality of life of elderly men. The number of patients is increasing every year.
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